An alternative approach for treatment of infantile esotropia with botulinum toxin A.

• Conditions: infantile esotropia; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-005068-82-NL
• Lead Sponsor: The Rotterdam Eye Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-19
• Last Update Posted: 15 April 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

- Infantile esotropia; age < 4 years,
- No known/established neurological disease.
- Onset of esotropia before 6 months without paralytic component.
- No vertical deviation (no upshoots).
- Non-accommodative (less than 3D spherical equivalent hyperopia).
- Up to 40 ? esotropia.
- Free alternators.
- Difference in refraction between both eyes = 1.5 D.

Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Previous strabismus surgery.
- Retinal disease.
- Any medical condition that would preclude general anesthesia with sevoflurane.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified